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. 2012 Dec 12;2012(12):CD008650. doi: 10.1002/14651858.CD008650.pub2

Hsu 2008.

Methods This was a randomised, double‐blind, placebo‐controlled clinical trial with a randomisation ratio of 1:1
Participants INCLUSION CRITERIA:
  • 16 to 60 year old*

  • BMI > 27 kg/m2


EXCLUSION CRITERIA:
  • endocrine disease, e.g. thyroid disorder, pituitary disorder, sex gland disorder

  • heart disease, e.g. arrhythmia, heart failure, myocardial infarction, patient with pacemaker

  • allergy and immunology disease

  • high aminotransferases (alanine, aspartate > 80 IU/L) or high serum creatinine (> 2.5 mg/dL)

  • pregnant or lactating women

  • childbirth within 6 months

  • stroke or otherwise unable to exercise

  • management for weight control within 3 months

  • any other conditions deemed unsuitable for trial as evaluated by physician‐in‐charge


DIAGNOSTIC CRITERIA:
  • height (measured with a wall‐mounted stadiometer to nearest 0.1 cm)

  • weight (measured on a calibrated balance beam scale to nearest 0.1 kg, after overnight fast, with subjects in undergarments and hospital gown)

  • BMI (calculated from previous 2 measurements)

Interventions NUMBER OF STUDY CENTRES: 1
COUNTRY/ LOCATION: Taiwan/Taipei
SETTING: hospital (outpatient clinic)
TREATMENT BEFORE STUDY: note: in the lead‐in period of 2 weeks, the patients should maintain weight and weight control within 0.5%
Outcomes OUTCOME(S) (as stated in the protocol/registered trial documents):
PRIMARY OUTCOME(S): per cent reduction of BMI and body weight
SECONDARY OUTCOME(S): per cent reduction of: glucose, cholesterol, LDL, HDL and triglycerides, leptin, adiponectin and ghrelin comparisons and analysis
OTHER OUTCOME(S): NR
Study details STUDY TERMINATED BEFORE REGULAR END: no
Publication details This study was published in English in Clinical Nutrition, a peer‐reviewed journal, and was supported by a grant from the National Science Council, Taiwan
Stated aim of study Quote from study: "thus, we conducted this randomised clinical trial to examine the effect of GTE [green tea extract] on obese women and to explore the relationship between GTE and obesity‐related hormone peptides."
Notes Our inclusion criteria state that we will only look at studies with participants over the age of 18. In this case, we contacted the author and learned that though the researchers would have accepted participants below the age of 18, no such participants were included in this study.
BMI: body mass index; HDL: high‐density lipoprotein; LDL: low‐density lipoprotein; NR: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from study: "a random number between 0.0 and 0.99 was generated by the computer for each subject. Subjects with a random number between 0.0 and 0.49 were assigned to the group with the GTE [green tea extract] while those with a random number between 0.50 and 0.99 were assigned to the placebo group with cellulose"
Comment: sequence generation was appropriate
Allocation concealment (selection bias) Low risk Comment: numbers were computer generated as each patient was enrolled therefore the group they would be allocated to was concealed and depended upon the computer to generate
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote from study: "a randomised, double‐blind, placebo‐controlled clinical trial was conducted"
"The same opaque capsules containing either dried powder GTE or placebo (cellulose) were administered to the subjects by a research assistant blinded to the contents in the capsules. All subjects were treated in the same fashion"
Comment: no mention of effectiveness of blinding efforts; however, care was clearly taken to blind both staff and participants
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: all outcomes on which the study reported were objective and measured by assessors. Therefore, whether or not assessors were blinded, risk of detection bias was assessed as low
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: study authors gave reasons that most but not all participants withdrew from the study. The number who did not complete the study was higher than for other studies: 9/50 in the intervention and 13/50 in the controlled group. It is unclear the effect that those who did not give reasons for withdrawal and those who withdrew because they did not see an effect may have had on results
Selective reporting (reporting bias) Low risk Comment: outcomes specified at the beginning were adequately investigated and reported
Other bias Low risk Comment: appears to be free of other bias